(1) Field of the Invention
The present invention relates to an adjustable, semi-rigid headgear for maintaining the proper positioning of a headgear for a noninvasive ventilation interface about a wearer's head and on the wearer's face. In particular, the present invention prevents the kinking of medical gas tubing and holds a nasal cannula in proper position as the wearer sleeps and/or changes their head's position.
(2) Description of the Prior Art
There are certain medical situations in which it is necessary or desirable to deliver a flow of breathing gas to the airway of a patient without intubating the patient or surgically inserting a tube in the patient's trachea. For example, a patient might be ventilated using a technique known as non-invasive ventilation. Non-invasive ventilation interfaces are also used with patients having a medical disorder such as sleep apnea who might require continuous positive airway pressure (CPAP) or Bilevel Positive Airway Pressure in which positive pressure is maintained during inspiration but reduced during expiration, and Intermittent Mechanical Positive Pressure Ventilation in which pressure is applied when an episode of apnea is sensed.
Such non-invasive ventilation and pressure support methodologies involve the placement of a patient non-invasive interface device, which is typically a nasal cannula or face mask or nasal pillows, on the face of a patient. The patient interface device communicates the flow of breathing gas from the ventilator or pressure support device with the airway of the patient, so that the therapeutic flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient. It is known to maintain such interface devices on the face of a wearer by a headgear having upper and lower straps, each having opposite ends threaded through connecting elements provided on the opposite sides and, on some, the top of the interface device. Because such devices are typically worn for an extended period of time, it is important that the headgear maintain the device in a tight enough seal against a patient's face or nose without discomfort.
Persons with medical conditions such as lung disease or those recovering from surgery often require supplemental oxygen. Usually, the supplemental oxygen is delivered through medical gas tubing attached to a nasal cannula or medical gas mask. Generally, some fastening means is needed to properly hold the nasal cannula or medical gas mask properly against a wearer's face.
There are problems with typical headgear used with these interface devices. Many patients find the harness, headband, or other headgear used to keep the mask in position uncomfortable, particularly when sleeping. The headband or harness must typically maintain the interface device against the face or nose of the wearer with some pressure, resulting in significant patient discomfort and irritation.
Examples of prior art fastening means include fabric headbands and fabric harnesses that fasten about a wearer's head. U.S. Pat. No. 6,684,833 to Burns discloses an example of the fabric headband type. Burns teaches a nasal cannula headband apparatus in which medical gas tubing is attached to the outer side of the headband by fasteners that keep the cannula tubing in place relative to the headband and direct the cannula tubing behind the wearer's ears. While this type of headband apparatus may be adequate for some patients, others will no doubt find the headband too uncomfortable for long term use because of restriction to blood vessels in their forehead region. Moreover, Burns does not teach a means to prevent the cannula tubing from kinking caused by the wearer's movements. U.S. Pat. No. 6,119,694 to Correa et al. discloses a harness type mask as shown in FIG. 2 of the disclosure's drawings. As with Burns, some patients will find this type of tubing fastening apparatus to be too restrictive to be comfortable. Moreover, Correa et al does not disclose a means to direct medical gas tubing such that it does not kink as the wearer changes positions while sleeping, etc. What is needed is a medical tubing fastening apparatus that does not restrict blood flow in the wearer's forehead, while also providing a means to prevent the medical gas tubing from kinking as the wearer changes head positions.
Additionally, fabric or elastic headbands or headgear often become tangled and twisted, and are therefore difficult for the user to easily place on the user's head. Additionally, the prior art headgear are often tightened significantly about the wearer's head in order to maintain the interface device in proper position. Lastly, the prior art headgear causes significant difficulty in properly locating the interface device on the wearer and requires significant adjustment. Thus, what is needed is a headgear that is simpler to place on the wearer's head, that does not become twisted or entangled, and that requires minimal adjustment for proper placement of the interface device.